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About this product

Division: International
Category: Vertebral Body Augmentation (inc Vertebroplasty, Kyphoplasty, Stentoplasty)


The CONFIDENCE® SPINAL CEMENT SYSTEM® combines unique highly viscous cement with a novel hydraulic delivery system. The radiopaque CONFIDENCE® High Viscosity Cement reaches a dough-like phase immediately after the cement components have been mixed, without going through a liquid phase. In addition, the viscosity of the CONFIDENCE® Cement remains relatively constant throughout the entire working time of 8–10 minutes (at a standard OR temperatures of 68F/20C). The hydraulic delivery system enables a smooth introduction of this highly viscous cement through a specially designed 10G, 11G, 13G or 15G introducer needle.

CONTROL THROUGH VISCOSITY:
High Viscosity Without the Wait

– The CONFIDENCE® High Viscosity Spinal Cement provides immediate post mixing high viscosity with optimal working time when compared to a major competitor.

 

CONTROL THROUGH DELIVERY:

– Hydraulic based delivery system allows for a controlled flow of highly viscous cement through a small gauge introducer needle.

CONTROL THROUGH SIMPLICITY:

– Novel mixing and transfer tools allow for simple streamlined set up.
– Seamless mixing and transfer in one bowl
– Contained cement transfer designed to limit vapours

 

Intended Use

INDICATIONS

The CONFIDENCE® SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE® Spinal Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), and malignant lesions (metastatic cancer, myeloma).

 

CONTRAINDICATIONS

The use of CONFIDENCE® High Viscosity Spinal Cement is contraindicated in patients presenting with any of the following conditions:

  • Use of CONFIDENCE® High Viscosity Spinal Cement for prophylaxis (such as in metastatic or osteoporotic patients with no evidence of acute vertebral fracture)
  • Coagulation disorders, or severe cardiopulmonary disease.
  • Haemorrhagic diasthesis.
  • Non-pathological, acute, traumatic fractures of the vertebra.
  • Patient clearly improving on medical therapy.
  • Spinal stenosis (> 20% by retropulsed fragments).
  • Compromise of the vertebral body or walls of the pedicles.
  • Compromise or instability of vertebral fractures due to posterior involvement.
  • Anatomical damage of the vertebra that prevents safe access of the needle to the vertebral body.
  • Vertebral body collapse to less than 1/3 (33%) original height.
  • Vertebral plana (collapse >90%)
  • Active or incompletely treated infection.
  • Coagulopathy or inability to reverse anti- coagulant therapy (both during and approximately 24 hours post-procedure).
  • Severe pulmonary insufficiency.
  • Allergic reaction to any of the components of the CONFIDENCE® High Viscosity Spinal Cement.


Limited Warranty and Disclaimer:

DePuy Synthes Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

 

WARNING

In the USA, this product has labelling limitations. See package insert for complete information.

 

CAUTION

USA Law restricts these devices to sale by or on the order of a physician.

Features & Benefits

  Features Benefits
High viscosity cement with decreased risk of cement leakage
  • Allows for reduced extravasation
  • Potential for fewer complications from cement leakage
Hydraulic based delivery system
  • Allows for precise delivery and placement of cement
  • Ability to reduce radiation exposure
Longer working time Treatment of multiple levels with one package allows for Increased efficiency and reduced costs

 

V0773A
Please refer to the surgical technique guide or package inserts if included for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative .
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